February 2013 FDA Recall Drug by Jubilant Cadista Pharmaceuticals Inc.
D-296-2013 - cGMP Deviations
This Class II drug recall was voluntarily initiated by Jubilant Cadista Pharmaceuticals Inc. on February 11, 2013 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-296-2013
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
02-11-2013
05-08-2013
12770 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Jubilant Cadista Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
12-23-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Pantoprazole Sodium Delayed Release Tablets USP, 40 mg, 90 count bottles, Manufactured by Jubilant Life Sciences Ltd, Roorkee-247661 India ;Marketed by Jubilant Cadista Pharmaceuatical Inc Salisbury, MD 21801 NDC 59746-284-90
Batch or Lot Expiration Information
Lot# Lot PA22028 Exp 5/2014 Lot PA22029 Exp 5/2014
